Multiple Cardiac Sensors for the Management of Heart Failure



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:August 15, 2017
End Date:January 2025
Contact:Stephen B Ruble, PhD
Email:stephen.ruble@bsci.com
Phone:651-582-4397

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The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial
intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic
feature.

Phase I of the MANAGE-HF trial is not randomized, and is intended to evaluate the clinical
integration of HeartLogic for managing patients with heart failure. There are no endpoints.

Phase II of the MANAGE-HF trial will assess the clinical effectiveness of remote monitoring
of heart failure patients with implanted CRT-D or ICD cardiac devices that contain the
diagnostic feature HeartLogic. This feature uses S1 and S3 heart sounds, night time heart
rate, thoracic impedance, and respiration to alert clinicians when a patient's heart failure
is worsening. The MANAGE-HF study will compare remote monitoring using HeartLogic alerts to
drive heart failure care against patients with remote monitoring but without HeartLogic
alerts.

Inclusion Criteria:

1. Subject is age 18 or above, or of legal age to give informed consent

2. Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) or
implantable cardioverter-defibrillator (ICD) device that has HeartLogic

3. Current symptomatic heart failure or New York Heart Association Class II or III at the
time of enrollment

4. Remotely monitored by LATITUDE 5.0 (or future versions)

5. Willing and capable of participating in all study visits and complying with
medication/treatment requirements associated with this clinical study at an approved
clinical study center.

6. Meet at least one of the three following conditions:

- At least one documented hospitalization with a primary diagnosis of worsening for
heart failure during the 12 months prior to enrollment; or

- Unscheduled outpatient visit with IV diuretic therapy for acute worsening of HF
during 90 days prior to enrollment; or

- N-terminal-pro brain natriuretic peptide (NT-proBNP) greater than 600 pg/mL or
brain natriuretic peptide (BNP) greater than 150 pg/mL at any time during 90 days
prior to enrollment

Exclusion Criteria:

1. The subject is unable to sign or refuses to sign the patient informed consent

2. Symptomatic heart failure at rest or New York Heart Association Class IV at the time
of enrollment

3. The subject is implanted with unipolar right atrial or right ventricular leads

4. Subject has received or is scheduled to receive a heart transplant or ventricular
assist device within the next 6 months

5. Subject is pregnant or planning to become pregnant during the study

6. Subject is enrolled in any other concurrent study (without prior written approval from
Boston Scientific, excluding registries)

7. Glomerular filtration rate <25 mL/min who are non-responsive to diuretic therapy or
are on chronic renal dialysis

8. Regularly scheduled intravenous heart failure therapy (for example inotropes or
diuretics)

9. A life expectancy of less than 12 months per clinician discretion

10. APPLICABLE TO PHASE II ONLY: Subject enrolled in Phase I of MANAGE-HF

11. APPLICABLE TO PHASE II ONLY: Subject has been managed with HeartLogic Alerts ON at
anytime within the past 6 months.
We found this trial at
27
sites
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Jonathan Piccini, MD
Phone: 919-681-8983
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Jooyoung Shin, MD
Phone: 718-920-8780
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Andrew Smith, MD
Phone: 404-712-0502
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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Aurora, Colorado 80045
Principal Investigator: Larry Allen, MD
Phone: 303-724-6473
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Beaumont, Texas 77702
Principal Investigator: Paris Bransford, MD
Phone: 409-839-4003
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Michael Gold, MD
Phone: 843-792-2944
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Cincinnati, Ohio 45219
Principal Investigator: Jay Dinnerman, MD
Phone: 256-519-8276
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Cincinnati, OH
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Cincinnati, Ohio 45242
Principal Investigator: Hemal Shah, MD
Phone: 513-865-1148
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1406 6th Avenue North
Cold Spring, Minnesota 56320
Principal Investigator: Moustapha Atoui, MD
Phone: 320-656-7020
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Fort Wayne, Indiana 46805
Principal Investigator: Mark O/Shaughn, MD
Phone: 260-266-5614
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Germantown, Tennessee 38138
Principal Investigator: David Lan, MD
Phone: 901-271-1000
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Principal Investigator: John Boehmer, MD
Phone: 717-531-5967
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Huntsville, Alabama 35801
Principal Investigator: Jay Dinerman, MD
Phone: 256-519-8290
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Indianapolis, Indiana 46256
Principal Investigator: Chad Bonhomme, MD
Phone: 317-621-8621
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Jonesboro, Arkansas 72401
Principal Investigator: Devi Nair, MD
Phone: 870-935-6729
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2051 Marengo St
Los Angeles, California 90033
Principal Investigator: Rahul Doshi, MD
Phone: 323-442-7983
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Manchester, New Hampshire 03102
Principal Investigator: Robert Capodilupo, MD
Phone: 603-669-0413
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Principal Investigator: John Herre, MD
Phone: 757-388-2812
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Oakland, California 94609
Principal Investigator: Steven Kang, MD
Phone: 925-274-2078
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Raleigh, North Carolina 27607
Principal Investigator: Sidharth Shah, MD
Phone: 919-784-4031
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Rochester, New York 14642
Principal Investigator: Atkas Mehmet, MD
Phone: 585-273-4128
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Saint Paul, Minnesota 55102
Principal Investigator: Alan Bank, MD
Phone: 651-241-2913
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7901 Frost Street
San Diego, California 92123
858-939-3400
Principal Investigator: Peter Hoagland, MD
Phone: 858-244-6889
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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San Francisco, California 94143
Principal Investigator: Byron Lee, MD
Phone: 415-768-5148
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Shreveport, Louisiana
Principal Investigator: Sherman Wiggins, MD
Phone: 318-795-4638
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Springfield, Oregon 97477
Principal Investigator: Matt Trojan, MD
Phone: 541-222-1927
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Yardley, Pennsylvania 19067
Principal Investigator: Christopher Schulze, DO
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